Ignite Creation Date:
2024-05-05 @ 11:26 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00032149
Status:
UNKNOWN
Last Update Posted:
2013-09-20
First Post:
2002-03-08
Brief Title:
Combination Chemotherapy Plus Filgrastim in Treating Patients With HIV-Related Non-Hodgkins Lymphoma
Sponsor:
Lymphoma Trials Office
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Pilot Study Of PMitCEBO Plus G-CSF In Good-Prognosis HIV-Related Lymphoma
Status:
UNKNOWN
Status Verified Date:
2007-03
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die Combining more than one drug may kill more cancer cells Colony-stimulating factors such as filgrastim may increase the number of immune cells found in bone marrow or peripheral blood and may help a persons immune system recover from the side effects of chemotherapy
PURPOSE Phase III trial to study the effectiveness of combining filgrastim with combination chemotherapy in treating patients who have HIV-related non-Hodgkins lymphoma
PURPOSE Phase III trial to study the effectiveness of combining filgrastim with combination chemotherapy in treating patients who have HIV-related non-Hodgkins lymphoma
Detailed Description:
OBJECTIVES
Determine the toxicity of mitoxantrone cyclophosphamide etoposide vincristine bleomycin prednisolone and filgrastim G-CSF in patients with good-prognosis defined by the study as having 1 adverse prognostic factor HIV-related non-Hodgkins lymphoma
Determine the effects of this regimen on response rate time to disease progression and survival in these patients
OUTLINE This is a multicenter study
Patients receive mitoxantrone IV cyclophosphamide IV and etoposide IV on day 1 and vincristine IV and bleomycin IV on day 8 Patients also receive prednisolone daily on weeks 1-4 and then every other day on weeks 5-16 Patients receive filgrastim G-CSF subcutaneously on days 6-12 Treatment repeats every 2 weeks for up to 8 courses 16 weeks in the absence of disease progression or unacceptable toxicity Patients with complete response CR or partial response PR receive 4 courses beyond CR or PR
Patients are followed every 3 months for 1 year every 6 months for 5 years and then annually thereafter
PROJECTED ACCRUAL A total of 15-30 patients will be accrued for this study
Determine the toxicity of mitoxantrone cyclophosphamide etoposide vincristine bleomycin prednisolone and filgrastim G-CSF in patients with good-prognosis defined by the study as having 1 adverse prognostic factor HIV-related non-Hodgkins lymphoma
Determine the effects of this regimen on response rate time to disease progression and survival in these patients
OUTLINE This is a multicenter study
Patients receive mitoxantrone IV cyclophosphamide IV and etoposide IV on day 1 and vincristine IV and bleomycin IV on day 8 Patients also receive prednisolone daily on weeks 1-4 and then every other day on weeks 5-16 Patients receive filgrastim G-CSF subcutaneously on days 6-12 Treatment repeats every 2 weeks for up to 8 courses 16 weeks in the absence of disease progression or unacceptable toxicity Patients with complete response CR or partial response PR receive 4 courses beyond CR or PR
Patients are followed every 3 months for 1 year every 6 months for 5 years and then annually thereafter
PROJECTED ACCRUAL A total of 15-30 patients will be accrued for this study
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| EU-20144 | None | None | None |
| BNLI-GOODRISKHIV | None | None | None |